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Press releases

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Oncopeptides provides an update from the meeting with FDAs advisory committee ODAC Regulatory

September 23, 2022
STOCKHOLM — September 23, 2022 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a biotech company focused on research and development of therapies for difficult-to-treat hematological diseases, today announces that the Oncologic Drugs Advisory Committee (ODAC), of the US Food and Drug Administration (FDA), has finalized the discussion on the benefit-risk profile of Pepaxto[®] (melphalan flufenamide, also called melflufen). A majority of the panel considered that OCEAN did not confirm a favorable benefit-risk profile in the current indicated patient population. Pepaxto is indicated in combination with dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM), who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody
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Briefing Book for ODAC meeting on benefit/risk profile of Pepaxto now published

September 20, 2022
STOCKHOLM — September 20, 2022 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a biotech company focused on research and development of therapies for difficult-to-treat hematological diseases, today announces that the US Food and Drug Administration (FDA), has published the Briefing Book for the Oncologic Drugs Advisory Committee (ODAC) meeting on September 22, 2022. The purpose of the meeting is to obtain the advisory committee´s input regarding the benefit/risk of Pepaxto[®] (melphalan flufenamide, also called melflufen) for the currently indicated patient population
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Oncopeptides receives 5 MSEK grant for NK-cell engager project in multiple myeloma

September 7, 2022
STOCKHOLM — September 7, 2022 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a biotech company focused on research and development of therapies for difficult-to-treat hematological diseases, today announces that the company has received a research grant of 5 MSEK from Sweden´s Innovation Agency, to develop preclinical proof of concept (PoC) for a novel synthetic small polypeptide for the treatment of multiple myeloma. The compound is a Natural Killer (NK) cell engaging immunotherapy, with superior tissue penetration and immune cell activation. The NK ENGAGE project has been qualified as a Eurostars program and will be driven by a research consortium including the department of Cancer Immunology at Oslo University Hospital, Norway, Pharmatest Services Ltd in Turku, Finland, and Oncopeptides, together with its collaborator the Royal Institute of Technology in Stockholm, KTH, where the technology originally stems from
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Extraordinary General Meeting in Oncopeptides AB (publ) Regulatory

August 30, 2022
The shareholders in Oncopeptides AB (publ), reg. no. 556596-6438, with registered office in the municipality of Stockholm, (“Oncopeptides” or the “Company”) are hereby given notice to attend the Extraordinary General Meeting to be held on Friday 23 September 2022
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European Commission approves Oncopeptides’ Pepaxti for the treatment of patients with relapsed refractory multiple myeloma Regulatory

August 18, 2022
STOCKHOLM — August 18, 2022 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a biotech company focused on research and development of therapies for difficult-to-treat hematological diseases, today announces that the European Commission has granted Pepaxti[®] (melphalan flufenamide, also called melflufen) marketing authorization in combination with dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least three prior lines of therapies, whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-CD38 monoclonal antibody, and who have demonstrated disease progression on or after the last therapy. For patients with a prior autologous stem cell transplantation, the time to progression should be at least 3 years from transplantation. The marketing authorization is valid in all EU member states, as well as in the European Economic Area (EEA) countries Iceland, Lichtenstein, and Norway
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Oncopeptides publishes Q2 report 2022 Regulatory

August 11, 2022
STOCKHOLM — August 11, 2022 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a biotech company focused on research and development of therapies for difficult-to-treat hematological diseases, today publishes the report for the second quarter 2022
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Number of shares and votes in Oncopeptides Regulatory

July 29, 2022
Stockholm, Sweden — July 29, 2022 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a biotech company focused on research and development of therapies for difficult-to-treat hematological diseases, today announces that the number of shares and votes in Oncopeptides has changed as a result of the company’s share issue as announced on July 14, 2022. As a result of the share issue, the number of outstanding shares and votes has increased by 15,061,443 from 75,307,217 to 90,368,660. The share capital has increased by approximately SEK 1,673,494 from SEK 8,367,469 to SEK 10,040,963
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FDA announces an Oncologic Drugs Advisory Committee meeting to discuss benefit/risk profile of Oncopeptides’ Pepaxto

July 20, 2022
STOCKHOLM — July 20, 2022 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a biotech company focused on research and development of therapies for difficult-to-treat hematological diseases, today announces that the US Food and Drug Administration (FDA), has announced a forthcoming public advisory meeting of the Oncologic Drugs Advisory Committee (ODAC), on September 22, 2022, to discuss the benefit/risk of Pepaxto[®] (melphalan flufenamide)
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Oncopeptides has carried out a directed share issue of approximately SEK 435.6 million (approximately USD 41.1 million) Regulatory

July 14, 2022
NOT FOR PUBLICATION, DISTRIBUTION OR RELEASE, DIRECTLY OR INDIRECTLY, IN WHOLE OR IN PART, IN OR INTO THE UNITED STATES OF AMERICA, THE UNITED KINGDOM, AUSTRALIA, CANADA, HONG KONG, ISRAEL, JAPAN, NEW ZEALAND, SOUTH AFRICA, SWITZERLAND OR ANY OTHER JURISDICTION WHERE SUCH PUBLICATION, DISTRIBUTION OR RELEASE WOULD BE UNLAWFUL OR REQUIRE REGISTRATION OR OTHER MEASURES
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Bulletin from the Annual General Meeting in Oncopeptides AB (publ) Regulatory

June 28, 2022
Stockholm, Sweden – June 28, 2022 – The Annual General Meeting in Oncopeptides AB (publ) (ONCO) was held on Tuesday, 28 June 2022. At the Annual General Meeting, the following principal resolutions were passed
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